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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

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HILL-ROM BATESVILLE PROGRESSA FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number P7500A000559
Device Problem Self-Activation or Keying (1557)
Patient Problem No Patient Involvement (2645)
Event Date 05/15/2020
Event Type  malfunction  
Manufacturer Narrative
The hillrom technician found the gci pod 8 series needed to be replaced.It is necessary for the progressa¿ bed to have an effective maintenance program.We recommend that you do annual preventive maintenance examine the motors for the presence and tightness of the attachment hardware.Replace as necessary.Fully raise and lower the bed.Make sure there is no friction or abnormal noises and no audible overload indication can be heard during the movement.Make sure the bed not down led lights up on the control pendant and goes out when the bed is in low position.Replace the defective motor(s) in the event of a malfunction.Troubleshoot in the event of a doubt.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the gci pod 8 series to resolve the issue.Based on this information, no further action is required.
 
Event Description
Hillrom technical support received a report from the account stating that the feet and knee section had a self run (was moving without engaging any buttons on the bed).The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
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Brand Name
PROGRESSA FRAME
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
HILL-ROM BATESVILLE
1069 state route 46 east
batesville IN 47006
Manufacturer Contact
harish vishwanathan
1069 state route 46 east
batesville, IN 47006
3127289851
MDR Report Key10150985
MDR Text Key195466957
Report Number1824206-2020-00258
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122473
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberP7500A000559
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/15/2020
Initial Date FDA Received06/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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